MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT; STRETCHER, WHEELED

Model Number 6506

Device Problems Use of Device Problem (1670); Device Tipped Over (2589)

Patient Problem Pain (1994)

Event Date 08/12/2020

Event Type  Injury  

Event Description

It was reported that a patient was injured while using the device.Further information has not been provided regarding this event.

Event Description

It was reported that a patient was injured while using the device.Further information has not been provided regarding this event.

Manufacturer Narrative

Multiple attempts were made to the initial reporter to request additional information, however no response was received.Since no further information was available, a possible hazard, defect, and injury details were not identified.Device was not available for evaluation.

• Brand Name: POWER PRO AMBULANCE COT
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10511120
• MDR Text Key: 206297138
• Report Number: 0001831750-2020-00901
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other